MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	2204243003 42
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Malfunction hazard/product is coming apart, in pieces, shredding, floating fluff [device breakage] yellow spots on the tampons [product contamination] i suspect that the product is counterfeit [suspected counterfeit product] case narrative: consumer reported via web that there were yellow spots and fluff on tampons.No injury reported.
Additional Manufacturer Narrative
There is insufficient information to perform an investigation.
Event or Problem Description
Malfunction hazard/product is coming apart, in pieces, shredding, floating fluff [device breakage].Yellow spots on the tampons [product contamination].I suspect that the product is counterfeit [suspected counterfeit product].Consumer reported via web that there were yellow spots and fluff on tampons.No injury reported.
Additional Manufacturer Narrative
Product investigation is in progress.
Additional Manufacturer Narrative
Product investigation is in progress.
Event or Problem Description
Malfunction hazard/product is coming apart, in pieces, shredding, floating fluff [device breakage] yellow spots on the tampons [product contamination] i suspect that the product is counterfeit [suspected counterfeit product] case narrative: consumer reported via web that there were yellow spots and fluff on tampons.No injury reported.

• Brand Name: TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED - HEB
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer Contact: manager affairs,feminine care ; winton hill business center b; 6280 center hill avenue; cincinnati 45224
• MDR Report Key: 17434521
• Report Number: 1219109-2023-00243
• Device Sequence Number: 8661103
• Product Code: HEB
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K081555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 2204243003 42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/11/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female